Common use of Written Standards Clause in Contracts

Written Standards. ‌ Within 120 days after the Effective Date, Sanofi shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Sanofi’s compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, Sanofi shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element in evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At a minimum, the Policies and Procedures shall address the following: a. appropriate ways to conduct Contribution and Assistance Related Functions in compliance with all applicable Federal health care program requirements, including but not limited to, the Federal Anti-Kickback Statute (codified at 42 U.S.C. § 1320a-7b(b)) and the False Claims Act (codified at 31 U.S.C.‌ §§ 3729-3733); b. arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. These Policies and Procedures shall be designed to ensure that Sanofi’s arrangements and interactions comply with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Sanofi’s arrangements and interactions (including donations‌ and sponsorship) comply with all guidance issued by OIG relating to the support and funding of patient assistance programs, including but not limited to, the OIG’s Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. 70623 (Nov. 22, 2005) and OIG’s Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs, 79 Fed. Reg. 31120 (May 30, 2014); c. the operation of, or participation in, any Sanofi PAP. These Policies and Procedures shall be designed to ensure that Sanofi’s operation of or in participation in such programs complies with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Sanofi’s operation of or participation in any such Sanofi PAP complies with all guidance issued by OIG relating to assistance provided to patients by pharmaceutical manufacturers to reduce or eliminate the cost of copayments for drugs, including but not limited to, the OIG’s Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons (Sept. 2014);‌ d. the materials and information that may be distributed by appropriate Sanofi personnel about Independent Charity PAPs or Contribution and Assistance Related Functions and the manner in, and circumstances under, which appropriate Sanofi personnel may respond to requests for information about Independent Charity PAPs or Contribution and Assistance Related Functions; and‌ e. appropriate ways to conduct Promotional Functions in compliance with all: (i) applicable Federal healthcare program requirements, including but not limited to, the Federal Anti-Kickback Statute and the False Claims Act, and‌‌

Written Standards. ‌ Within 120 days after the Effective Date, Sanofi Astellas shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and Sanofi’s Astellas’ compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, Sanofi Astellas shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element in evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At a minimum, the Policies and Procedures shall address the following: a. appropriate ways to conduct Contribution and Assistance Related Functions in compliance with all applicable Federal health care program requirements, including but not limited to, the Federal Anti-Kickback Statute (codified at 42 U.S.C. § 1320a-7b(b)) and the False Claims Act (codified at 31 U.S.C.‌ U.S.C. §§ 3729-3733); b. arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. These Policies and Procedures shall be designed to ensure that Sanofi’s Astellas’ arrangements and interactions comply with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Sanofi’s Astellas’ arrangements and interactions (including donations‌ donations and sponsorship) comply with all guidance issued by OIG relating to the support and funding of patient assistance programs, including but not limited to, the OIG’s Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. 70623 (Nov. 22, 2005) and OIG’s Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs, 79 Fed. Reg. 31120 (May 30, 2014); c. the operation of, or participation in, any Sanofi Astellas PAP. These Policies and Procedures shall be designed to ensure that Sanofi’s Astellas’ operation of or in participation in such programs complies with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that Sanofi’s Astellas’ operation of or participation in any such Sanofi Astellas PAP complies with all guidance issued by OIG relating to assistance provided to patients by pharmaceutical manufacturers to reduce or eliminate the cost of copayments for drugs, including but not limited to, the OIG’s Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons (Sept. 2014);‌2014); d. the materials and information that may be distributed by appropriate Sanofi Astellas personnel about Independent Charity PAPs or Contribution and Assistance Related Functions and the manner in, and circumstances under, which appropriate Sanofi Astellas personnel may respond to requests for information about Independent Charity PAPs or Contribution and Assistance Related Functions; and‌ e. appropriate ways to conduct Promotional Functions in compliance with all: (i) applicable Federal healthcare program requirements, including but not limited to, the Federal Anti-Kickback Statute and the False Claims Act, and‌‌

Written Standards. ‌ Within 120 days after the Effective Date, Sanofi Lundbeck shall develop and implement written policies and procedures regarding the operation of its compliance program, including the compliance program requirements outlined in this CIA and SanofiLundbeck’s compliance with Federal health care program requirements (Policies and Procedures). Throughout the term of this CIA, Sanofi Lundbeck shall enforce its Policies and Procedures and shall make compliance with its Policies and Procedures an element in evaluating the performance of all employees. The Policies and Procedures shall be made available to all Covered Persons. At a minimum, the Policies and Procedures shall address the following: a. appropriate ways to conduct Contribution and Assistance Related Functions in compliance with all applicable Federal health care program requirements, including but not limited to, the Federal Anti-Kickback Statute (codified at 42 U.S.C. § 1320a-7b(b)) and the False Claims Act (codified at 31 U.S.C.‌ U.S.C. §§ 3729-3733); b. arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. These Policies and Procedures shall be designed to ensure that SanofiLundbeck’s arrangements and interactions comply with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that SanofiLundbeck’s arrangements and interactions (including donations‌ donations and sponsorship) comply with all guidance issued by OIG relating to the support and funding of patient assistance programs, including but not limited to, the OIG’s Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, 70 Fed. Reg. 70623 (Nov. 22, 2005) and OIG’s Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs, 79 Fed. Reg. 31120 (May 30, 2014); c. the operation of, or participation in, any Sanofi PAPpatient assistance program by Lundbeck or any entity acting on behalf of Lundbeck. These Policies and Procedures shall be designed to ensure that SanofiLundbeck’s operation of or in participation in such programs complies with all applicable Federal health care program requirements. The Policies and Procedures shall also be designed to ensure that SanofiLundbeck’s operation of or participation in any such Sanofi PAP patient assistance program complies with all guidance issued by OIG relating to assistance provided to patients by pharmaceutical manufacturers to reduce or eliminate the cost of copayments for drugs, including but not limited to, the OIG’s Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons (Sept. 2014);‌2014); d. the materials and information that may be distributed by appropriate Sanofi Lundbeck personnel about Independent Charity PAPs or Contribution and Assistance Related Functions and the manner in, and circumstances under, which appropriate Sanofi Lundbeck personnel may respond to requests for information about Independent Charity PAPs or Contribution and Assistance Related Functions; and‌ e. appropriate ways to conduct Promotional Functions in compliance with all: (i) applicable Federal healthcare program requirements, including but not limited to, the Federal Anti-Kickback Statute and the False Claims Act, and‌‌